Inspection Record
Inspectors Jazmine N. BrownThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Media fills were not performed that closely simulated aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.
Disinfecting agents and cleaning wipes used in the ISO 5 area aseptic processing areas are not sterile.
The facility design was observed to allow the influx of poor quality air into higher classified area.
(D) ( 4) and then cleaning the work surfaces and equtpment insiac of the ISO 5 LAFW bench area.
The ISO-classified areas have difficult to clean, particle-generating, or visibly dirty equipment or surfaces.
Biological indicators were not used to verify the adequacy of the sterilization cycle.
Environmental monitoring was not performed in your aseptic processing areas.
Personnel were observed conducting aseptic manipulations or placing equipment/supplies in an area that blocked the movement of first pass air around uncapped syringes, whether before or after it is filled with sterile product.
Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area.
Extracted automatically from the document US FDA published on 2023-01-30. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
Growth stages previewSolve a quiz to start hatching
Your growth record is stored safely in this browser.
